Prescription drug · ANDA
Desmopressin Acetate NDC 68083-549
Desmopressin acetate 4 ug/mL · Injection, Solution · Intravenous, Subcutaneous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-549-01 | 68083054901 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-549-01) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 20, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desmopressin Acetate
- Generic name (nonproprietary)
- desmopressin acetate
- Active ingredients
- Desmopressin acetate — 4 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216904
- Marketing start
- Listing expires
- Other FDA classes
- Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
- Identifiers
- Product ID 68083-549_87b1a5b9-034c-401b-9be9-236571d01e14SPL ID 87b1a5b9-034c-401b-9be9-236571d01e14SPL set ID 848d5173-ce26-46bf-b180-7ed13f0233b5RxCUI 849501UNII XB13HYU18U
- Pharmacologic class
- Factor VIII Activator; Vasopressin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468083054901followed by a unit qualifier and the quantityPackage 68083-0549-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Desmopressin acetate injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. ( 1.1 ) Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.2 ) von Willebrand’s disease (Type I) - for patients with mild to moderate disease w…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216904
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 65219-295 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Sun Pharmaceutical Industries Limited | 70095-031 |